Toripalimab (1) – Loqtorzi®
Recurrent or metastatic nasopharyngeal carcinoma (NPC), first-line treatment, in combination with cisplatin and gemcitabine
Characteristics
| Start date | 15.01.2026 – Marketing authorisation: 19.09.2024 |
|---|---|
| Resolution | 02.07.2026 |
| Limitation date | 15.01.2027 |
| INN | Toripalimab |
| Brand name | Loqtorzi® |
| Pharm. company | LEO Pharma GmbH |
| G-BA Procedure ID | D-1272 |
| ATC code | L01FF13 PD-1/PDL-1 inhibitors (L01FF) |
| Therapeutic area | Oncological diseases |
| Reason for procedure | Initial assessment |
Studies and Results
- Clinical trials
- For the benefit assessment, the pharmaceutical manufacturer presents the results from the completed, double-blind, multicentre, randomised, controlled trial JUPITER-02 comparing toripalimab in combination with cisplatin and gemcitabine against cisplatin in combination with gemcitabine.
Adults with recurrent nasopharyngeal carcinoma who are not eligible for surgery or radiotherapy, or who have metastatic nasopharyngeal carcinoma; first-line treatment
- The additional benefit is not proven.
- Consequently, there are no suitable data available overall for an assessment of additional benefit.
- Conclusion
- The data presented from the JUPITER-02 study are not suitable for assessing additional benefit, as the comparator therapy does not correspond to the appropriate comparator therapy specified for this resolution.
- An additional benefit of toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of recurrent nasopharyngeal carcinoma in adults who are not candidates for surgery or radiotherapy, or who have metastatic disease, is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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